G/SPS/N/EU/762  
8 May 2024  
(24-3659) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Cereals (HS codes: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 
1008), foodstuffs of animal origin (HS codes: 0201, 0202, 0203,  0204, 0205, 0206, 0207, 
0208, 0209, 0210) and certain products of plant origin, including fruit and vegetables  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Regulation amending Annexes II and 
III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as 
regards maximum residue levels for isopyrazam in or on certain products (Text with EEA 
relevance) . Language(s):  English . Number of pages:  4+1+13+12 
https://members.wto.org/crnattachments/2024/SPS/EEC/24_03129_00_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_03129_01_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_03129_02_e.pdf  
https://member s.wto.org/crnattachments/2024/SPS/EEC/24_03129_03_e.pdf  
6. Description of content:  The proposed draft Regulation concerns the review and update 
of existing MRLs for isopyrazam in certain food commodities. MRLs for these  substances in 
certain commodities are lowered. MRLs for these substances in certain commodities are 
changed. Lower MRLs are set after deleting old uses which are not authorised any more in 
the European Union as the approval of the use of the active substa nce withdrawn by 
Commission Implementing Regulation (EU) 2022/782 [1]. 
[1] Commission Implementing Regulation (EU) 2022/782 of 18 May 2022 withdrawing the approval of 
the active substance isopyrazam in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council co ncerning the placing of plant protection products on the market, 
amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing 
Regulation (EU) No 1037/2012 . 
(OJ L 140, 19  May 2022, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2022/782/oj ). 
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Codex Maximum Residue Limits f or isopyrazam in 
some commodities. CODEX MRLs LIST is available at https://www.fao.org/fao -
who-codexalimentarius/codex -texts/dbs/pestres/pesticid es/en/ . G/SPS/N/EU/762  
 
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  [ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  The European Food Safety Authority published reasoned opinion 
on the existing  MRLs for isopyrazam. Based on the opinion, Regulation (EC) No 396/2005 
should be amended following a risk analysis approach.  
The current EU policy is to align EU MRLs with CXLs if the following conditions are fulfilled: 
(i) that the European Union sets MR Ls for the commodity under consideration; (ii) that the 
current EU MRL is lower than the CXL; and (iii) that the CXL is acceptable to the 
European  Union with respect to its policy objective of ensuring a high level of consumer 
protection, including aspects  on supporting data and extrapolations.  
Where the E uropean Union considers that a proposed CXL is not acceptable, it makes a 
reservation to the Codex Committee on Pesticide Residues (CCPR). Reservations made by 
the European Union, concerning some of the ac tive substances envisaged by the draft 
Regulation, are listed in the relevant CCPR reports:  
http://www.fao.org/fao -who-codexalim entarius/committees/committee/related -
meetings/en/?committee=CCPR . 
9. Other relevant documents and language(s) in which these are available:   
− Regulation (EC) No 396/2005 of the European Parliament and of the Council of 
23 February 2005 on maximum residue levels of pesticides in or on food and feed of 
plant and animal origin and amending Council Directive 91/414/EEC  
http://eur -lex.europa.eu/legal -content/EN/ALL/?uri=CELEX%3A32005R0396  
− European Food Safety Authority; Reasoned opinion on the review of the existing 
maximum residue levels for isopyrazam according to Article 12 of Regulation (EC) 
No 396/2005; EFSA Journal 2021;19(7):6684  
https://doi.org/10.2903/j.efsa.2021.6684  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : 24 January 2025 
Proposed date of publication (dd/mm/yy) : 24 February 2025  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : This Regulation shall enter into force on the twentieth day following its 
publication in the Official Journal of the European Union, and apply six months thereafter.  
[ ] Trade facilitating measure   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 7 July 2024  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  G/SPS/N/EU/762  
 
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  13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu